Principal Scientist – Scientific Integrator Full-time

Principal Scientist Scientific Integration

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Within the Pharmaceutical Product Development & Supply (PPDS) organization we are recruiting a Principal Scientist Scientific Integration, based in the greater area of Antwerp, Belgium.

The Scientific Integrator is the PPDS representative and single point of contact on the CMC (Chemistry Manufacturing & Controls) new product development teams. The Scientific Integrator serves as the lead for a PPDS sub-team composed of specialists in Oral Solid Dosage Development, Parenterals & Liquids Development, Pharmaceutical and Material Sciences, and Drug Delivery Systems. The Scientific Integrator will integrate and align Drug Product Development activities to deliver project milestones within established cost, time and quality, and will offer strategic and scientific direction across PPDS/CMC functions.

Tasks & Responsibilities:

• Implements the Drug Product development strategy for synthetic drug candidates across all clinical phases including regulatory submissions in major and regional markets, and transition to supply chain operations.
• Develops and delivers robust clinical and commercial formulations and scalable manufacturing processes, informed by a deep understanding of compound properties and the Target Product Profile, to achieve required performance and cost targets.
• Acts as matrix leader to drive project delivery through collaboration within PPDS and cross-functional partnership within the CMC teams, CDT (preclinical and clinical) teams, and the commercial organization.
• Ensures compliance with applicable scientific, quality and regulatory standards throughout development and transfer activities
• Serves as the PPDS representative on the CMC core team, facilitating critical interactions with API and analytical integration partners, supply chain, Quality Assurance, CMC Regulatory Affairs, and external consultants and vendors
• Co-leads the Biopharm team — comprising CMC, clinical, preclinical, regulatory, non-clinical safety and other relevant functions — to select appropriate formulations consistent with the required pharmacokinetic profile, define bridging strategies, establish clinically relevant controls, and derive accurate product specifications.
• Maintain comprehensive understanding of product and process to lead and support drug product development and troubleshooting.
• Leads governance reviews for assigned projects, communicating program status, risks and decision proposals to governance bodies
• Maintains the Drug Product risk register and develops mitigation plans to ensure timely identification, escalation and resolution of issues.
• Ensure all PPDS activities are aligned and integrated to meet project deliverables efficiently.

Qualifications:

• A master's degree or PhD in Chemistry, Pharmacy, Biochemical Engineering, Chemical Engineering, or a related field, together with a minimum of three years' relevant professional experience, or an equivalent combination of education and experience.

Experience & Skills:

• Demonstrated high level of scientific and technical competence across drug product development, with the ability to interpret and apply formulation, process and compound-specific data.
• Consistent track record in process scale-up across clinical phases and in the technical transfer of projects into commercial manufacturing.
• Established leadership in coordinating integrated activities and delivering essential information across multifunctional teams and multiple sites.
• Outstanding communication skills with proven adaptability to constantly evolving project strategies and priorities.
• Decisive, with the ability to make prompt, well-reasoned decisions and to provide strong follow-through and organizational oversight to ensure team and organizational alignment.
• Ability to influence stakeholders and secure alignment in a matrix environment without direct line authority.
• Excellent written and oral communication skills, with proven competence in conflict management and negotiation.
• This position is based in Beerse, Belgium, and may require up to 5% domestic and international travel.

Our offer:

• An exciting position in an international and dynamic environment with continuous learning and growth opportunities.
• Working on a site that harbors all aspects of the drug discovery process, located close to the vibrant city of Antwerp.
• A competitive salary, on-site sport accommodations, health/energy programs and other benefits for you and your family.